LEADING CANCER CENTERS TO PRESENT DATA FROM DELCATH'S CHEMOSAT/MELPHALAN HDS AT ESSO CONGRESS
New York, NY- October 28, 2014 - Delcath Systems, Inc. (NASDAQ: DCTH) announced today that data highlighting the potential of the Company's Hepatic CHEMOSAT® Delivery System/Melphalan HDS will be presented as part of the scientific program at the upcoming European Society of Surgical Oncology (ESSO) congress. Three abstracts detailing the clinical experiences at three leading cancer hospitals using CHEMOSAT/Melphalan HDS to perform percutaneous hepatic perfusion (PHP) will be presented:
A Single Institution Experience with Percutaneous Hepatic Perfusion for Unresectable Ocular Melanoma and Sarcoma in the Liver---Moffitt Cancer Center, U.S.; J. Zager
Percutaneous Hepatic Perfusion with Melphalan in Treating Unresectable Liver Metastases from Colorectal Cancer and Uveal (Ocular) Melanoma - Leiden University Medical Centre (LUMC), The Netherlands; N. de Leede
Initial United Kingdom Experience with Melphalan Percutaneous Hepatic Perfusion (PHP) For Treatment of Inoperable Ocular Melanoma Metastases---University Hospital Southampton, U.K; B. Stedman
The ESSO congress will be held at Arena and Convention Centre Liverpool, in Liverpool, United Kingdom from October 29-31, 2014.
"We are pleased to see the research and clinical experiences of these institutions included in the scientific program of this year's ESSO Congress. We believe it reflects the growing interest physicians have in both Europe and the United States in the potential of PHP with CHEMOSAT/Melphalan/HDS to treat cancers in the liver." said Dr. Jennifer Simpson, interim CEO and President of Delcath Systems.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology. Our proprietary product-Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS)-is designed to administer high dose chemotherapy to the liver, while controlling the systemic exposure to those agents. The Company's principal focus is on the treatment of primary and metastatic liver cancers. In the United States, the Melphalan/HDS system is considered a combination drug and device product, and is regulated as a drug by the United States Food and Drug Administration (FDA). The Melphalan/HDS system has not been approved for sale in the United States. In Europe, our proprietary system to deliver and filter melphalan hydrochloride is marketed as a device under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT). In April 2012, we obtained authorization to affix a CE Mark for the Generation Two CHEMOSAT system. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT system in Europe. The Company has commenced a global phase 2 clinical trial in Europe to investigate Melphalan/HDS system for primary liver cancer and is initiating plans to evaluate intrahepatic cholangiocarcinoma.
Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the impact of the presentations at ESSO and future clinical results consistent with the data presented, timely enrollment and treatment of patients in the Global Phase 2 HCC and ICC clinical trial, IRB or ethics committee clearance of the Phase II HCC and/or ICC protocol from additional participating sites and the timing of site activation and subject enrollment in the HCC and ICC Phase II trial program, the timing and results of clinical trials including without limitation the HCC, ICC and OM clinical trial program, approval of Individual Funding Requests for reimbursement of the CHEMOSAT procedure, the impact, if any of Value 4 status on potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe including the key markets of Germany and the UK, the Company's ability to successfully commercialize the Melphalan HDS/ CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT system as a treatment for patients with primary and metastatic disease in the liver, our ability to obtain reimbursement for the CHEMOSAT system in various markets, the Company's ability to satisfy the requirements of the FDA's Complete Response Letter and provide the same in a timely manner, approval of the current or future Melphalan HDS/CHEMOSAT system for delivery and filtration of melphalan or other chemotherapeutic agents for various indications in the US and/or in foreign markets, actions by the FDA or other foreign regulatory agencies, the Company's ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects, our ability to maintain NASDAQ listing, and uncertainties regarding the Company's ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
|Investor Contact:||Media Contact:|
|Michael Polyviou/Doug Sherk||John Carter|
|EVC Group||EVC Group|